Roles of microRNAs in the Development of Osteoporosis in Men - Preliminary Study

• Conditions: Osteoporosis
• Interventions: Other: Normal; Other: Osteoporosis; Other: Osteopenia

• Registration Number: NCT02705040
• Lead Sponsor: Taipei Medical University WanFang Hospital

Brief Summary

This study is aimed to evaluate the roles of specific miRNAs in osteoporosis in men.

Detailed Description

In the past, osteoporosis is usually viewed as a woman disease. However, men and women are shown to lose their bone mass at the same rate by more than 65 of age, and osteoporosis in men causes higher mortality in men than those in women. Thus, osteoporosis in men has recently aroused public attention. Androgen deficiency was the main cause leading to osteoporosis. Bone structure is maintained by a dynamic balance of osteoblast-mediated bone formation and osteoclast-mediated bone resorption. Androgens and androgen receptor (AR) play critical roles in regulation of bone formation and resorption. MicroRNAs (miRNAs) are non-coding small RNAs and participate in regulating activities of osteoblasts and osteoclasts by postranslationally targeting certain gene expressions. miR-133 and -135 can target BMP-2, Runx2, and Smad5 and then regulate osteoblast differentiation. Likewise, miR-141 and -200a negatively regulated osteoblast differentiation. Nevertheless, the functional roles of miRNAs in osteoporosis in men are still unknown. In addition, miRNA are stable and can be detected in the blood as novel biomarkers for certain diseases. A recent study analyzed the levels of miRNAs in circulating monocytes of 10 high and 10 low bone mineral density postmenopausal Caucasian women and found miR-133a is a potential biomarker for postmenopausal osteoporosis. In comparison, the roles of blood miRNAs in osteoporosis in men have not been evaluated. Therefore, this study is aimed to evaluate the roles of specific miRNAs in osteoporosis in men.

Study Timeline

• Study Start: 2013-12
• Status Verified: 2016-01
• Study First Submitted: 2016-01-29
• Study First Submitted QC: 2016-03-06
• Last Update Submitted: 2016-03-06
• Study First Posted: 2016-03-10
• Last Update Posted: 2016-03-10
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1. Twenty oriental men (mean age, 80 years; age range, 70-90 years).
2. Candidates have no clinical evidence or history of focal lesions of the femur; previous hip surgery or irradiation; hip trauma; spinal trauma.
3. Participants who have thoroughly understood and signed the consent form.
4. Ten normal adult male (age range, 20-40 years).

Exclusion Criteria

1. Participants with secondary causes of osteoporosis, such as thyroid, parathyroid disease, osteogenesis imperfect and osteomalacia.
2. Participants with Paget's disease, serious liver disease, serious renal disease (indicated by a serum creatinine concentration of more than 1.6mg/dL).
3. Participants who currently or have history of using steroids or hormone replacement therapy.
4. Participants who fail to sign to the consent form.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal	Osteoporosis	bone mineral density T\>=-1.0
Osteopenia	Normal	bone mineral density -1.0\>T\>=-2.5
Osteopenia	Osteoporosis	bone mineral density -1.0\>T\>=-2.5
Osteoporosis	Normal	bone mineral density T\<-2.5
Osteoporosis	Osteopenia	bone mineral density T\<-2.5
Normal	Osteopenia	bone mineral density T\>=-1.0

Primary Outcome Measures

Name	Time	Method
Bone mineral density	30 minutes	T scale

Trial Locations

Locations (1)

Taipei Medical University Wanfang Hospital; 🇨🇳 Taipei, Taiwan